US20240081808A1 - Devices and methods for tissue repair - Google Patents

Abstract

Methods and devices for tissue fixation. A cortical button with a rib between two slotted openings. The rib increases the cortical button structural rigidity without increasing palpability. An adjustable loop construct with two discrete locking passages that provides manageable loop reduction and improved tissue coupling. The adjustable loop construct may be coupled to tissue via a passing construct. An assembly with a reduction bar, a button and an adjustable loop construct, the assembly provided assembled in a first configuration that disassembles to guide steps of tissue fixation. The reduction bar may be assembled to the reduction bar for reducing the adjustable loop construct.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a PCT Application which claims the benefit of U.S. Provisional App. No. 63/179,654 filed Apr. 26, 2021 titled “DEVICES AND METHODS FOR TISSUE REPAIR” and U.S. Provisional App. No. 63/278,644 filed Nov. 12, 2021 and titled “DEVICES AND METHODS FOR TISSUE REPAIR” all herein incorporated by reference in their entirety.
FIELD
• The present disclosure relates to methods and devices for joint repair, including graft fixation in a surgical repair.
BACKGROUND
• Native soft tissue (such as ligaments and tendons of a joint) that is damaged may generally be replaced or repaired arthroscopically. For some joint repairs, a tissue fixation system with an adjustable loop construct may be coupled to a graft (and/or also the native soft tissue) and inserted along a bone tunnel. The adjustable loop construct may then be adjusted or reduced to position the graft in a target location along the bone tunnel and fixed in place with a tissue anchor, such as a cortical button. Cortical buttons may define a thin body to lie flat on a bone external surface and limit palpability, while supporting the fixation loading on the adjustable construct. Related art cortical buttons may bend under this fixation loading. Related art adjustable loop constructs may loosen via loop slip or creep under this loading. Related art adjustable loop constructs may require extreme forces to reduce the adjustable loop construct and position the graft. Related art fixation systems may require complicated assembly and management to stage the steps of the procedure. Related art fixation systems may require high forces during coupling of the grafts to the system, potentially damaging the tissue and/or grafts, or the adjustable loop construct. There is therefore a need for an improved fixation system with associated methods that address the related art shortcomings.
SUMMARY
• Described herein are various improvements in methods and devices for tissue fixation using a loop construct that may be adjustable and may be formed with a flexible strand. A flexible strand may comprise suture, suture tape, cable, wire or ribbon. The suture may comprise a hollow braided suture. Such improvements may include examples of tissue anchors that are partially assembled with an adjustable loop construct, and further assembled after the adjustable loop construct has been coupled to a tissue, a graft or a second tissue anchor. The tissue anchor is preferably configured to remain sufficiently rigid to withstand the tissue fixation loads. Such improvements may include an adjustable loop construct that affords loop reduction with accessible hand tension, while also providing a knotlessly locked configuration that withstands physiological cyclic loading. Such improvements may include an assembly including a reduction handle with a tissue anchor and an adjustable loop construct housed therein, the assembly arranged in such a way as to manage the steps of releasing the adjustable loop construct and anchor from the reduction handle for coupling the adjustable loop to the tissue, graft or second tissue anchor. The handle may also be configured to re-assemble with the adjustable loop construct for reducing the adjustable loop and positioning the tissue, graft or second tissue anchor. Such improvements may include a passing construct operatively coupled to the adjustable construct in an arrangement that reduces passing forces required to thread the adjustable loop strands through a tissue or graft. Such improvements may include a method of attaching soft tissue or graft to an adjustable loop construct that concomitantly forms a low-profile end of the soft tissue or graft and provides a secure attachment.
• For example, a cortical button is disclosed herein that is an oblong body, having a length greater than a width. The oblong body extending from a first end to a second end and defining a longitudinal axis. The width extends from a first sidewall to a second sidewall, the first and second sidewalls extending between the first and second ends along and either side of the longitudinal axis. The body also includes a lower surface configured to engage an external bone surface. The body further includes a pair of slotted apertures extending through an entire thickness of the body for receiving a loop of flexible strand therethrough. The button includes a rib extending from the body lower surface and disposed between the pair of slotted apertures and coextensive along the longitudinal axis with the pair of slotted openings. The cortical button configured to be passed through a bone tunnel in an elongate orientation.
• Some example button embodiments may also include a pair of enclosed apertures, adjacent the pair of slotted apertures. The rib may also be disposed between the pair of enclosed apertures and coextensive along the longitudinal axis with the pair of enclosed apertures. The cortical button may also include a first end aperture disposed between the pair of slotted apertures and first end, and a second end aperture disposed between the pair of enclosed apertures and second end. The first and second end apertures may be axially separated from the rib. The rib may be an oblong solid body and may have a longitudinal axis coincident with and parallel to the cortical button longitudinal axis. The pair of slotted apertures may each define medial surfaces that extend through the cortical button thickness and are continuous with outer lateral side surfaces of the rib. The pair of slotted apertures may each define a lateral opening through one of the first or second sidewalls, and wherein the rib is configured to compensate for a reduced structural integrity of the cortical button, the reduced structural integrity a result of the lateral openings. The rib may extend perpendicularly from the lower surface, less than 2 mm from the cortical button oblong body. The rib may extend from the lower surface defining a tib thickness that is less than the body thickness.
• Another example cortical button is disclosed that is an oblong body, having a length greater than a width, the length extending from a first end to a second end with a longitudinal axis extending therebetween. The width extends from a first sidewall to a second sidewall, the first and second sidewalls extending between the first and second ends along and either side of the longitudinal axis. The body also includes a lower surface configured to engage an external bone surface. The body also includes a pair of slotted apertures extending through an entire thickness of the body for receiving a loop of a flexible strand therethrough. The button anchor includes a rib extending from the lower surface and disposed between the pair of slotted apertures and coextensive along the longitudinal axis with the pair of slotted openings. The body width defines a minimum diameter of a bone tunnel through which the cortical button may be passed, the rib configured to increase the structural integrity of the cortical button while preserving the minimum diameter.
• In some example embodiments, the pair of slotted apertures each define a lateral opening through one of the first or second sidewalls, and the rib is configured to increase the structural integrity and compensate for a loss of structural integrity due to the lateral openings. The body may also include a pair of enclosed apertures, adjacent the pair of slotted apertures, the rib disposed between the pair of enclosed apertures and coextensive along the longitudinal axis with the pair of enclosed apertures. The pair of slotted apertures may each define a lateral opening through one of the first or second sidewalls, and wherein the rib is coextensive along the longitudinal axis with the lateral openings. The button body may also include a first end aperture and a second end aperture, both axially separated from the rib. The rib may be an oblong solid body. The rib may be an oblong body having a longitudinal axis coincident with and parallel to the cortical button longitudinal axis. The pair of slotted apertures may each define medial surfaces that extend through the cortical button thickness and are continuous with outer lateral side surfaces of the rib. The rib may extend perpendicularly from the lower surface, less than 2 mm from the cortical button body. The rib may extend from the lower surface a distance that is less than a thickness of the body.
• An adjustable tissue repair system is also disclosed including a tissue anchor with a plurality of apertures therethrough. The system also includes an adjustable loop construct formed from a flexible strand and coupled to the tissue anchor via the plurality of apertures. The adjustable loop construct includes a first adjustable eyesplice loop extending through a first pair of apertures of the plurality of apertures. The adjustable loop construct also includes a second adjustable eyesplice loop configured to couple to a second pair of apertures of the plurality of apertures. The adjustable loop construct also includes a saddle portion extending between the first and second adjustable eyesplice loops and disposed at an opposite end of the adjustable loop construct to the tissue anchor. The adjustable loop construct also includes a first and second limb, the first limb tensionable for shortening the first adjustable eyesplice loop and the second limb tensionable for shortening the second adjustable eyesplice loop.
• In some example embodiments, the first and second eyesplice loops each include a locking passage, and wherein each locking passage includes two lengths of the flexible strand therethrough. The saddle portion may define three lengths of the flexible strand extending therealong, between locking passages. One of the three lengths of these flexible strands may be a static strand, such that while adjusting the adjustable loop construct, the static strand does not slide. Static strand defines a fixed or non-adjustable length portion of the adjustable loop construct. The fixed length may be between 0.10-0.5 inches. The fixed length during ACL repair may be about 0.25 inches. The tissue repair system may also include a passing construct including a threading member and a flexible loop, the flexible loop coupled to the saddle portion of the adjustable loop construct. The saddle portion may include three lengths of the flexible strand and wherein the flexible loop may be threaded between the three lengths in a complex loop, to limit sliding of the flexible loop along the adjustable loop construct. The flexible loop may be threaded between the three lengths of flexible strand of the saddle portion to stagger insertion of the three lengths through a graft. The flexible loop may be coupled to the saddle portion and form a figure-of-eight loop around the three lengths of the flexible strand. The figure-of-eight loop may include a first loop that loops around a static length of the three lengths of the flexible strand, and a second loop that loops around two dynamic lengths of the three lengths of flexible strand. The plurality of openings through the tissue anchor may include a pair of lateral slotted openings configured to selectively receive the second adjustable eyesplice loop therethrough. The saddle portion may couple directly to graft or tissue. The first and second eyesplice loops may each extend from a first and second locking passage respectively, and the first eyesplice loop and first limb both extend from a first end of the first locking passage and the second eyesplice loop and second limb both extend from a first end of the second locking passage.
• Another adjustable tissue repair system embodiment is disclosed including a tissue anchor with a plurality of apertures therethrough and an adjustable loop construct formed from a flexible strand and coupled to the tissue anchor via the plurality of apertures. The adjustable loop construct may include a first adjustable eyesplice loop extending from a first locking passage, the first adjustable eyesplice loop extending through a first pair of apertures of the plurality of apertures. The adjustable loop construct may include a second adjustable eyesplice loop extending from a second locking passage, the second adjustable eyesplice loop configured to couple to a second pair of apertures of the plurality of apertures. The adjustable loop construct may include a saddle portion extending between the first and second adjustable eyesplice loops, disposed at an opposite end of the adjustable loop construct to the tissue anchor. The adjustable loop construct may include a first and second limb, the first limb tensionable for shortening the first adjustable eyesplice loop and the second limb tensionable for shortening the second adjustable eyesplice loop. The system may include a passing construct including a threading member coupled to a flexible loop, the flexible loop coupled to the saddle portion.
• In some example embodiments, the saddle portion includes three lengths of the flexible strand. One of the three lengths of the flexible strand may be a static length of the adjustable loop construct extending between and continuous with the first and second locking passage. The static length may be between 0.10-0.5 inches long. The flexible loop of the passing construct may be threaded between the three lengths of flexible strand of the saddle portion to stagger insertion of the three lengths through a graft. The flexible loop may be coupled to the saddle portion and form a figure-of-eight loop around the three lengths. The figure-of eight loop may define a first loop that loops around a static length of the three lengths of flexible strand, and a second loop that loops around two dynamic lengths of the three lengths of flexible strand. The first eyesplice loop and the first limb may both extend from a first end of the first locking passage and the second eyesplice loop and the second limb may both extend from a first end of the second locking passage.
• An example method of coupling an adjustable tissue repair construct to a graft is also disclosed, the method including obtaining an adjustable tissue repair construct that includes a button, an adjustable loop construct and a passing construct. The button includes a plurality of openings therethrough. The adjustable loop construct is formed with a flexible strand and coupled to the button via the plurality of openings at a first end of the adjustable loop construct. The passing construct includes a flexible strand loop and a threading member, the flexible strand loop separately formed from the adjustable loop construct and coupled to a second end of the adjustable loop construct, at the opposing end to the first end. The method includes forming a stitched region in the graft by first passing the passing construct through the graft in a first direction toward a clamped end of the graft to attach the adjustable loop construct to the graft and then passing the passing construct though the graft in an opposite direction towards a free end of the graft to attach the flexible strand loop to the graft.
• In some example methods, advancing the passing construct in the first direction, further comprises drawing the adjustable loop construct through and around the graft at a location spaced away from both the clamped end and free end. The method may include passing the passing construct through the graft adjacent the adjustable loop construct that is threaded around the graft, and thereby locking the adjustable loop construct in place along the graft. Passing the passing construct in the opposite direction may wrap the flexible strand loop around the graft and also over and around the adjustable loop construct. Passing the passing construct in the opposite direction may form at least two whipstitches along and through the graft.
• The method may also include passing the passing construct in the opposite direction up to a free end edge of the graft, tying a knot in the flexible strand loop at the free end edge, removing the threading member from the flexible strand loop, leaving a remaining length of flexible strand loop; and drawing the free end of the graft through and along a prepared bone tunnel via the remaining length.
• The flexible strand loop may form a figure-of-eight loop, a first loop of the figure-of-eight loop looped around a first strand of a plurality of strands of the adjustable loop construct at the second end, and a second loop of the figure-of-eight loop looped around a second strand of a plurality strands and wherein passing the passing construct in a first direction first passes the second loop and therefore the second strand through the graft, and then passes the first loop and therefore the first strand through the graft. Passing the passing construct in the second direction may leave the first loop of the figure-of-eight loop on a first side of the graft and passes the second loop of the figure-of-eight loop through the graft.
• Another example method of coupling a suspensory fixation system to a graft is disclosed, the suspensory fixation system including an adjustable loop construct and a passing construct linked thereto. The method includes forming a first stitched region along the graft by inserting the passing construct through the graft and advancing the passing construct in a first direction toward a clamped end of the graft to stitch the adjustable loop construct through and along the graft. The method also includes forming a second stitched region by inserting the passing construct through the graft and advancing the passing construct in second direction toward a free end of the graft to stitch a flexible loop of the passing construct through and along the graft, the second stitched region overlapping the first stitched region.
• In some of these example methods, advancing the passing construct in the first direction begins along a length of the graft spaced away from the free end. Forming the first stitched region may begin at a location along the graft that is about 2 cm from the free end. Inserting the passing construct through the graft and advancing the passing construct in the first direction may include inserting the passing construct a first time to stitch the adjustable loop construct through the graft followed by inserting the passing construct a second time through the graft to secure the adjustable loop construct in place along the graft. Advancing the passing construct in the second direction may include inserting the passing construct a third time and a fourth time through the graft at axially spaced locations, to form a plurality of stitches through the graft with the flexible loop. Passing the passing construct, a third time, may place the flexible loop over the adjustable loop construct. of claim54 wherein inserting the passing construct through the graft a first, second, third and fourth time comprises passing the needle from a top external surface of the graft to a bottom external surface of the graft. After forming the first and second stitched region, the method may include tensioning the flexible loop to form the graft free end into a tapered cylinder. The method may also include drawing the free end into a prepared bone tunnel by drawing the flexible loop through the prepared bone tunnel first and then the graft free end.
• In some example methods, the flexible loop may form a complex loop, a first loop of the complex loop looped around a first strand of a plurality of strands of the adjustable loop construct, and a second loop of the complex loop looped around a second strand of the plurality of strands and wherein forming the first stitched region may insert the second loop through the graft first, followed by the first loop, and thereby stagger the insertion of the plurality of strands to reduce a force required to form the first stitched region. Forming the second stitched region may leave the first loop of the complex loop on a top side of the graft and may pass the second loop of the complex loop through the graft. The flexible loop may include a complex loop including a first and second loop, each loop looped around different strands of the adjustable loop construct and advancing the passing construct in second direction may advance only one of the first or second loops.
• A reduction bar is also disclosed herein, for managing an adjustable loop construct with a passing construct and a button attached thereto, the reduction bar including a plurality of channels, spools, recesses, and slots therethrough. The reduction bar houses the passing construct, the adjustable loop construct, and the button in a first configuration within the plurality of channels, slots, and spools, in an arrangement that stages the release of the assembled components. The passing construct may be release first, followed by the adjustable loop construct and then the button from the reduction bar to couple the adjustable loop construct to a tissue, graft, or tissue anchor. Once disassembled, the reduction bar may then assemble again to the adjustable loop construct in a second configuration that is different than the first configuration. In this second configuration the reduction bar may be used to reduce a loop of the adjustable loop construct and draw the tissue, graft, or tissue anchor towards the button upon tension being applied via the reduction bar to the adjustable loop construct.
• In some example embodiments the reduction bar includes a slot of the plurality of slots that extends along a longitudinal axis of the reduction bar, the slot continuous with a recess, the slot configured to retain a threading member of the passing construct and the recess configured to allow access to an end of the threading member to remove the threading member from the reduction bar. In the second configuration, a first looped limb of the adjustable loop construct may encircle a segment of a first spool of the reduction bar, the segment defined by a notch through the first spool. In the second configuration rotating the reduction bar around a reduction bar longitudinal axis may first form a fold along the first looped limb to limit slipping of the first looped limb around the first spool. The reduction bar may house the button so as to expose two slotted apertures of the button. The reduction bar may house a first portion of the adjustable loop construct around a first spool of the plurality of spools and a second portion of the adjustable loop construct around a second spool of the plurality of spools.
• Another example embodiment of a reduction handle is disclosed that houses and manages an adjustable loop construct. The adjustable loop construct includes a first end assembled to a cortical button and a second end coupled to a threading element for coupling the second end to a tissue, a graft, or a tissue anchor. The reduction handle defines a longitudinal axis and opposed lateral ends and also includes a slot at one of the lateral ends for retaining the cortical button. The slot may also orient a slotted opening of the cortical button for selectively receiving the adjustable loop second end therethrough. The reduction handle may also include a means of housing the threading element and a means directly adjacent thereto for accessing and selectively removing the threading element from the reduction handle. The reduction handle may also include a first and a second spool extending around an outer surface of the handle, a first and a second loop of the adjustable loop construct receivable in the first spool and second spool respectively.
• In some example embodiments the means of housing the threading element includes a plurality of circumferential ribs defining a channel on an external surface of the reduction handle, and wherein a cavity in the handle at an end of the channel defines the means of accessing and selectively removing the threading element. The first and second spools may each define an outermost channel defining a first path, each outermost channel intersected by a corresponding notch defining a second path around a segment of the first path of each spool. The first loop of the adjustable loop construct may be receivable along the notch of the first spool so as to place the first loop along the second path around the first spool. The second loop of the adjustable loop construct may be receivable along the notch of the second spool to place the second loop along the second path around the second spool. The second path around each spool may be configured to form a fold in each loop of the first and second loop and limit spinning of the first and second loop while rotating the handle about its longitudinal axis.
• A method of repairing a tissue with a reduction bar is also disclosed, the reduction bar preassembled to an adjustable loop construct, a cortical button, and a threading element. The method may include removing the adjustable loop construct and the threading element from the reduction bar and coupling the adjustable loop construct to a tissue, a graft or a tissue anchor. The method may include coupling a first and a second loop end of the adjustable loop construct to the reduction bar after it has been removed. Tension may then be applied on the first and second loop end via the reduction bar to reduce the adjustable loop construct and draw the tissue, graft, or tissue anchor towards the cortical button.
• In some example methods, removing the adjustable loop construct and the threading element may include removing the threading element from a channel of the reduction bar, followed by unspooling a first portion of the adjustable loop construct from a first spool of the reduction bar. Coupling the adjustable loop construct may include inserting the adjustable loop construct through the tissue, graft, or tissue anchor with the threading member. Removing the adjustable loop construct and the threading element from the reduction bar may occur while retaining the button housed within the reduction handle. Coupling may also include coupled a free looped end of the adjustable loop construct to the cortical button after coupling the adjustable loop construct to a tissue, graft, or tissue anchor. Coupling the free looped end may include inserting the threading member through an aperture of the button while the button is housed within the reduction bar, with an aperture external to the reduction bar.
• Coupling the first and a second looped ends may include inserting the first looped end along a first notch of the reduction bar to place the first looped end around a segment of a first spool on the reduction bar and inserting the second looped end along a second notch of the reduction bar to place the second looped end around a segment of a second spool of the reduction bar. The method may also include rotating the reduction bar around a longitudinal axis to wrap the first and second looped ends around an outermost surface of the first and second spool respectively and thereby reduce a length of the first and second looped end. Rotating the reduction bar and applying tension on the first and second looped ends may be performed sequentially and repeatedly. The method may include removing the button after coupling the adjustable loop construct to a tissue, graft or tissue anchor and before coupling a first and a second looped end to the reduction bar.
• These and other features and advantages will be apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of aspects as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
• The disclosure will be more fully understood by reference to the detailed description, in conjunction with the following figures, wherein:
• FIG.1A illustrates a perspective view of a ribbed cortical button, in accordance with this disclosure;
• FIG.1B illustrates a bottom view of the ribbed cortical button, in accordance with this disclosure;
• FIG.1C illustrates an end view of the ribbed cortical button, in accordance with this disclosure;
• FIG.1D illustrates a side view of the ribbed cortical button, in accordance with this disclosure;
• FIG.1E illustrates a cross section view of the ribbed cortical button through B-B (shown inFIG.1B), in accordance with this disclosure;
• FIG.1F illustrates a cross section view of the ribbed cortical button through A-A (shown inFIG.1B), in accordance with this disclosure;
• FIG.1G illustrates an offset cross section view (from the longitudinal axis) of the ribbed cortical button through C-C (shown inFIG.1B), in accordance with this disclosure;
• FIG.2A illustrates a perspective view of another ribbed cortical button embodiment, in accordance with this disclosure;
• FIG.2B illustrates a bottom view of the ribbed cortical button, in accordance with this disclosure;
• FIGS.3A-3F illustrate an example method of coupling a graft to a ribbed cortical button, in accordance with this disclosure;
• FIG.3G illustrates a ribbed cortical button assembled with an adjustable loop construct and assembled with a bone tunnel, in accordance with this disclosure;
• FIG.4A illustrates a top view of a low-profile cortical button in accordance with this disclosure;
• FIG.4B illustrates a perspective view of the low-profile cortical button, in accordance with this disclosure;
• FIG.4C illustrates a bottom view of the low-profile cortical button, in accordance with this disclosure;
• FIG.4D illustrates a side view of the low-profile cortical button, in accordance with this disclosure;
• FIG.4E illustrates a cross section view of the low-profile cortical button, in accordance with this disclosure;
• FIG.5A illustrates a perspective view of a low-profile cortical button, in accordance with this disclosure;
• FIG.5B illustrates another perspective view of the low-profile cortical button, in accordance with this disclosure;
• FIG.5C illustrates a top view of the low-profile cortical button, in accordance with this disclosure;
• FIG.5D illustrates a bottom view of the low-profile cortical button, in accordance with this disclosure;
• FIG.5E illustrates a side view of the low-profile cortical button, in accordance with this disclosure;
• FIG.6A illustrates a view of an adjustable loop construct coupled to a low-profile cortical button, in accordance with this disclosure;
• FIG.6B illustrates a closer view of an adjustable loop construct coupled to a low-profile cortical button, in accordance with this disclosure;
• FIG.7 illustrates an adjustable loop construct with two locking passages in accordance with this disclosure;
• FIGS.8A-8C illustrate a method of forming the adjustable loop construct inFIG.7 in accordance with this disclosure;
• FIG.9A illustrates another adjustable loop construct with two locking passages in accordance with this disclosure;
• FIGS.9B-9C formation of the adjustable loop construct with two locking passages in accordance with this disclosure;
• FIG.10 illustrates another adjustable loop construct with four locking passages in accordance with this disclosure;
• FIG.11A illustrates a perspective view of a reduction bar in accordance with this disclosure;
• FIG.11B illustrates a front side view of the reduction bar in accordance with this disclosure;
• FIG.11C illustrates another view of the reduction bar with a button assembled thereto, in accordance with this disclosure;
• FIG.11D illustrates a bottom view of the reduction bar with a button anchor assembled thereto, in accordance with this disclosure;
• FIG.11E illustrates a top view of the reduction bar with a button anchor assembled thereto, in accordance with this disclosure;
• FIG.12A illustrates a suspension fixation system, and portions thereof, in accordance with this disclosure;
• FIGS.12B and12C illustrate portions of the suspension fixation system assembled to the reduction bar, in accordance with this disclosure;
• FIG.13A illustrates an adjustable loop construct assembled to the reduction bar in a reducing configuration, in accordance with this disclosure;
• FIG.13B illustrates a cross section of a reduction bar spool, assembled to a loop of the adjustable loop construct limb, in accordance with this disclosure;
• FIG.13C illustrates the looped end of the adjustable loop construct limb wrapped around the cross section of a reduction bar spool, in accordance with this disclosure;
• FIG.13D illustrates a method of reducing a length of the adjustable loop construct limbs (step1) and also the adjustable loop construct perimeter (step2) in accordance with this disclosure;
• FIG.14 illustrates an adjustable loop construct with a passing loop construct coupled thereto, in accordance with this disclosure;
• FIG.15 illustrates a saddle portion of an adjustable loop construct with a passing loop construct coupled thereto with a figure-of-eight, in accordance with this disclosure;
• FIGS.16A-16B illustrate views of a saddle portion of an adjustable loop construct with a passing construct coupled thereto in a split luggage tab configuration, in accordance with this disclosure;
• FIGS.17A-17J illustrates a method of coupling an adjustable loop construct and passing loop construct to a graft, in accordance with this disclosure; and
• FIG.18A illustrates a top view of a stitched arrangement after the first pass (FIG.17E) according the method disclosed inFIG.17A-17J; and
• FIG.18B illustrates a top view of a final stitched arrangement according the method disclosed inFIG.17A-17J.
DETAILED DESCRIPTION
• In the description that follows, like components have been given the same reference numerals, regardless of whether they are shown in different examples. To illustrate example(s) in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in somewhat schematic form. Features that are described and/or illustrated with respect to one example may be used in the same way or in a similar way in one or more other examples and/or in combination with or instead of the features of the other examples.
• As used in the specification and claims, for the purposes of describing and defining the invention, the terms “about” and “substantially” are used to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The terms “about” and “substantially” are also used herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. “Comprise,” “include,” and/or plural forms of each are open ended and include the listed parts and can include additional parts that are not listed. “And/or” is open-ended and includes one or more of the listed parts and combinations of the listed parts. Use of the terms “upper,” “lower,” “upwards,” and the like is intended only to help in the clear description of the present disclosure and are not intended to limit the structure, positioning and/or operation of the disclosure in any manner.
• Some of the constructs disclosed herein incorporate “locking passages”. These may sometimes be referred to in the art as splices, eyesplices, cradles, suture locking regions, cinches, finger cinches, finger traps, longitudinal passages or dilated regions. They are defined by a length of a braided flexible strand with a hollow core that may receive an elongate strand therethrough. The elongate strand may be a different portion of the flexible strand, or another separate flexible strand and may extend along a path that extends from outside the braided flexible strand (and outside the locking passage) then between the braids to enter the hollow core (lumen) and then exit through the braided wall a distance along the braided flexible strand later. Multiple lengths of flexible strands may extend along and through the hollow core at spaced apart locations, thereby defining multiple locking passages. Multiple lengths of an elongate strand may extend along and through the hollow core at the same location. The braided flexible strand may be dilated first to form a dilated or laterally extended length before receiving the elongate member therein. The locking passage is configured such that tension on the braided hollow flexible strand contracts the radius thereof and thereby locks or cinches around the elongate strand extending therein, locking the elongate strand in place. This defines a “locking passage”. The flexible strand may be a suture, suture tape, ribbon, or flexible tubular cable.
Cortical Button Embodiments
• FIG.1A illustrates a perspective view of a cortical button100 (hereinafter “button100”), in accordance with example embodiments.Button100 operatively couples to a flexible strand30 (shown inFIGS.3A-3H) via a plurality of openings forming passages through thebutton100.Flexible strand30 may be a suture, tape, wire or cable and may be formed in an adjustable loop construct, disclosed in more detail hereinafter.Button100 andflexible strand30 may couple to a graft and suspend the graft along a bone tunnel, for repair of an ACL of a patient's knee for example. In other example joint repairs,button100 andflexible strand30 may couple to another tissue anchor such as a second button, or a soft anchor or other tissue anchors known in the art. When coupled to another tissue anchor,button100 andflexible strand30 may couple a first bone to a second bone, or a first bone segment to a second bone segment, wherein the segments may be parts of the same bone. For example,button100 may form a portion of a repair construct for AC joint or ankle syndesmosis repair.
• Button100 may define a passing button; in that it is generally an oblong body with a width that is smaller in dimension than a length thereof. Passing buttons may be oriented in a passing orientation to pass through a bone tunnel, the bone tunnel approximating the anchor width, allowing the bone tunnel to be kept to a minimal opening size. Once through the bone tunnel, flipping thebutton100 to a deployed configuration (shown inFIG.3G) prevents retrograde motion of thebutton100 into the tunnel, as the button length is greater than the bone tunnel opening size. In the deployedconfiguration button100 engages the cortical bone outer surface.Button100 may be a flat, oblong unibody with rounded edges.Button100 is preferably thin to limit palpability above the cortical bone surface.
• Button100 may include a plurality of apertures therethrough, each aperture sized to receive aflexible strand30 therethrough and couple theflexible strand30 to the button.Flexible strand30 may be at least partially formed in a plurality of loops, in the form of an adjustable loop construct (discussed more inFIGS.3A-3H), and the plurality of apertures may couple the adjustable loop construct to thebutton100. The plurality of apertures may be sized to allow theflexible strand30 to slide.
• More specifically,button100 may include a pair ofapertures110a,110bthat may define 360 degree (°) bounded holes.Apertures110a,110bmay be disposed directly opposite each other on opposing sides of the button longitudinal axis L-L.Apertures110a,110bmay define oblong or oval shaped openings having a length along the longitudinal axis L-L greater than a corresponding width.Apertures110a,110bmay be sized and spaced relative to each other to slidingly receive a first loop of an adjustable loop construct, formed offlexible strand30. First loop may be provided pre-assembled to thebutton100, and therefore may be referred to as the assembled loop.Button100 may also include a pair of slottedapertures120a,120bthat have each have a lateral opening (121a,121b), thelateral openings121a,121bfor receiving a second loop of the adjustable loop construct therethrough to assemble the second loop to thebutton100 during the procedure. As such slottedapertures120a,120bmay be provided separated from the second loop, and the second loop may be assembled to thebutton100, entering vialateral openings121a,121bduring the surgical procedure. Second loop may therefore be referred to as a free loop. Slottedapertures120a,120bmay define oblong or oval shaped openings similar toapertures110a,110bhaving a length along the longitudinal axis longer than a width. Slottedapertures120a,120bmay be disposed directly opposite each other on opposing sides of the button longitudinal axis L-L. Slottedapertures120a,120bandapertures110a,110bmay have the same opening size and shape, with the exception that slottedapertures120a,120bincludeslateral openings121a,121b.
• Button100 defines an elongate body having opposed rounded ends105a,105bandlateral sides106a,106b.Apertures110a,110b,120a,120bmay be arranged towards acentral portion138 of thebutton100 spaced away from both ends105a,105b. Button also includes another pair ofapertures135a,135b.Aperture135ais disposed between thecentral portion138 andlateral end105a.Aperture135bis disposed between thecentral portion138 andlateral end105b.Apertures135a,135bmay be larger in opening size relative toapertures110a,110b,120a,120band may define oblong apertures, as defined herein.
• Button100 also defines anupper surface108 andlower surface107, that may both be smooth and planar. Upper andlower surface108,107 may define planar surfaces that are parallel to each other. Buttonlower surface107 is configured to engage an external portion of a bone. In some embodiments buttonlower surface107 may be contoured to match an external surface of the targeted bone surface. Buttons with apertures and slotted apertures and example adjustable loop constructs are disclosed in commonly owned PCT patent application number PCT/US20/038401 filed Jun. 18, 2020, titled “METHODS AND DEVICES FOR TISSUE GRAFT FIXATION” commonly owned and herein incorporated by reference in its entirety.
• As discussed herein, surgical fixation systems with cortical buttons may operate to couple to and suspend a graft within and along a bone tunnel of an articulating joint, and therefore experience load during use. Having a button that assembles to an adjustable loop construct during the procedure as opposed to providing the button completely preassembled, may provide improved methods for coupling the fixation system to a graft. However, thelateral openings121a,121bthat accommodate inter-procedural assembly may reduce structural integrity of button, relative to apertures that enclosed (360 degree bounded holes). This may be compensated for by increasing an overall thickness (T) of the button body, however increasing thickness may increase palpability or local tissue irritation, and therefore is less preferable.Button100 therefore includes anoblong rib140 extending fromlower surface107, configured to increase button rigidity and compensate for a button configured to receive a free loop of aflexible strand30 during the procedure.Rib140 is sized to fit within and extend along a bone tunnel whilesurface107 engages the external cortical surface of the bone surrounding the bone tunnel.Rib140 is configured to increase the button structural rigidity under functional loading without increasing the thickness (T) of the button that stands proud of the bone external surface.Rib140 may be configured to compensate for this reduced structural integrity, while maintaining a minimal thickness T.
• Rib140 may also help to center theelongate button100 and hinder the button from moving relative to the bone tunnel axis.Rib140 therefore has a length that extends substantially across an opening size (diameter) of a bone tunnel and also substantially axially into and along the bone tunnel, while still fitting along the limited bone tunnel diameter; the limited bone tunnel diameter defined by a width of the button body, as shown inFIG.1C. Stated in another way, with reference toFIG.1C, the cross section of the button including the button body and rib has an outer peripheral boundary that lies within a diameter (øD) defined by a width of the button body. For example, for a tunnel opening diameter of 4.5 mm, button body width may be between 4.2 mm, the rib length is preferably less than 4.0 mm and greater than 2.0 mm. More specifically in this example, rib length may be 3.5 mm in length L_Rand approximately 2 mm in width.Rib140 may extend at least 1.5 mm (T_R) from a button body lower surface.Rib140 may be a solid cross section or hollow, as its purpose is to maintain the button location relative to the bone tunnel, more so than any structural rigidity. As such, example rib could be an annular oblong ring, or a plurality of smaller posts at spaced apart locations configured to lie within the target bone tunnel and maintain a location of the button relative to the bone tunnel axis.
• Seen perhaps best inFIG.1B,rib140 is disposed along the longitudinal axis L-L and in-betweenapertures110a,110b,120a,120b.Rib140 is also disposed along thecentral portion138 of thebutton100.Rib140 may be equally spaced from ends105a,105b.Rib140 has a length L_Rthat extends along the longitudinal axis L-L, withapertures135a,135bdisposed, adjacent ends ofrib140.Rib140 andapertures135a,135bmay lie along the longitudinal axis L-L. Longitudinal axis may bifurcate therib140 andapertures135a,135b.Rib140 is axially spaced from bothapertures135a,135b.Rib140 may have a width that is narrower than a corresponding width ofapertures135a,135b. Rib length L_Rmay approximate a bone tunnel diameter thereby fitting within the bone tunnel and allowingsurface107 to engage bone outer surface. Rib length L_Rmay axially overlap at least a portion of bothapertures110a,110b, and120a,120b.Rib140 may preferably axially overlaplateral openings121aand121b.Rib140 may axially overlap entirelateral openings121a,121b. Stated in another way,rib140 defines an elongate body having first and second ends141a,141b, wheresecond end141bis disposed axially closer to button end105bthan both of thelateral openings121a,121bin their entirety.Second end141bmay also be disposed axially closer to button end105bthan both of the slottedapertures120a,120b, in their entirety.Rib140 is configured to add structural reinforcement to thebutton100, allowing the thickness T that protrudes above the bone surface to remain low in profile.Rib140 may compensate for a reduced structural integrity, the reduced structural integrity due to thelateral openings121a,121b.
• Best seen inFIG.1A andFIG.1G,rib140 may define planar side surfaces143a,143b, that may be parallel to longitudinal axis L-L and to each other. Planar surfaces143a,143bmay be coincident with medial edge surfaces111a,111b,122a,122bof slottedapertures120a,120bandapertures110a,110b. Planar surfaces143a,143bmay be continuous with medial edge surfaces111a,111bofapertures110a,110band medial edge surfaces122a,122bof slottedapertures120a,120brespectively. Medial edge surfaces111a,122aandplanar surface143amay all lie on a single planar vertical surface. Medial edge surfaces111b,122bandplanar surface143bmay all lie on a single planar vertical surface.
• Illustrated inFIG.1E andFIG.1F,rib140 extends fromlower surface107 and may define a solid cross section, free of voids.Rib140 may extend perpendicularly from buttonlower surface107, defining a rib thickness T_R. The combined thickness of button “T” and rib “T_R” may be equal to or less than a width ofbutton100, so as to fit along bone tunnel (FIG.1C).FIG.1C illustrates an example bone tunnel having diameter “øD”, relative to thebutton100 that is in the elongate (passing) orientation.Rib140 may extend 1-3 mm (T_R) fromlower surface107.Rib140 may define alower surface142 that is planar, thelower surface142 parallel withlower surface107. In other embodiments,lower surface142 may be curved.
• In other embodiments cortical button may include four apertures that all define 360 degree bounded holes, in similar locations toapertures110a,110,120a,120b. These example cortical buttons may be oblong, may be passing buttons as defined herein and may also include an oblong rib, similar torib140. While compensation for slots such asslots121a,121bis not required in this embodiment, inventors have found that these buttons may also benefit from the centering aspect provided by therib140.
• FIGS.2A and2B illustrate another example ribbedbutton200, similar toembodiment100 except where noted. In this embodiment,apertures210a,210b,220a,220bmay define circular shaped openings.Rib240 may definelateral surfaces243a,243bcoincident with medial edge surfaces211a,211b,222a,222bofapertures210a,210b,220a,220b.Lateral surfaces243a,243bmay be concave surfaces.Lateral surfaces243a,243bmay be continuous with medial edge surfaces211a,211b,222a,222bofapertures210a,210b,120a,220band eachaperture210a,210b,120a,220bmay define a single curved vertical surface through a thickness of thebutton200 that includes therib240. Stated in another way therib240 may conform to the shape of medial surface of apertures.Rib240 preferably axially overlaps at least theslot lateral openings221a,221b.Rib240 may extend further towards both button ends205a,205bthanapertures210a,210b,220a,220b.
• An example method of tissue repair with abutton100 is illustrated inFIGS.3A-3G.Button200 may alternatively be used. To prepare for the tissue repair a tunnel14 (FIG.3G) through at least onebone10 of a joint may first be formed, and agraft5 with abone block6 may be obtained. Ahole6amay be drilled through thebone block6. Asuspensory fixation system280 including abutton100 partially assembled to aflexible strand30 may be obtained, theflexible strand30 formed in anadjustable loop construct32. The adjustable loop construct32 may include a first limb or first loopedend33aand a second limb or second loopedend33b, an assembledadjustable loop35aand a freeadjustable loop35b. Assembledadjustable loop35amay be provided or obtained pre-assembled to thebutton100 via the two apertures, similar toapertures110a,110b.Button100 may include a rib140 (not shown inFIGS.3A and3B for simplification of these figures). At least one locking passage38 (as defined herein) may be formed byflexible strand30.Button100 may be passed through bone tunnel14 with the assembledadjustable loop35apreassembled.Button100 may then be flipped to engage an external cortical surface of bone10 (FIG.3G).
• Second loopedend33band freeadjustable loop35bmay be coupled totissue graft5. Second loopedend33band freeadjustable loop35bmay be obtained or provided coupled to a passingconstruct300. Passingconstruct300 may be passed throughbone block hole6ato draw loopedend33band freeadjustable loop35bthrough thebone block6. Passingconstruct300 may be passed throughbone block hole6ato draw lockingpassage38 throughbone block hole6aandplace locking passage38 within thebone block hole6a.Bone block hole6amay be sized to receive thelocking passage38, and thelocking passage38 may include at least three lengths offlexible strand30. After coupling the adjustable loop construct32 to thegraft5, freeadjustable loop35bmay be separated from passing construct300 (FIG.3B) and looped over thetop side108 of button (button100 shown) and into slottedapertures120a,120b, as shown inFIG.3C-3D. While inserting freeadjustable loop35binto slottedapertures120a,120b, loopedend33bmay remain coupled to passingconstruct300. Loopedend33bmay then be inserted throughaperture135b(FIG.3E-3F) using the passingconstruct300, before separating passingconstruct300 from loopedend33b. Suspension construct is now coupled tograft5 and is in a closed assembly configuration, with the loopedend33bandadjustable loop end35bassembled tobutton100 and the passingconstruct300 separated therefrom. Suspension construct in the closed assembled configuration may then be passed through the bone tunnel14.
• Loopedend33bmay be inserted throughaperture135b, using threadingmember305 of passing loop construct300 (FIG.3G). Tension on limb ends33a,33bmay reduce the adjustable loop construct32 to drawgraft5 towardsbutton100.FIG.3G illustratesbutton100 engaged over a bone tunnel14 formed throughbone10 and engaging a cortical layer ofbone12.Rib140 extends into bone tunnel14. For a tunnel diameter of 4.5 mm, therib140 may preferably have a length L_Rthat is less than 4.5 mm.Rib140,240 may be approximately 3.5 mm in length L_Rleaving room for limb ends33a,33bto route aroundrib140,240 and extend throughapertures135a,135b.Rib140 may be between 1-2 mm wide and may more preferably be approximately 1.3 mm wide.Rib140,240 may extend into the bone tunnel14 between 1-2 mm.
• In alternative methods, the adjustable loop construct32 may be coupled to another tissue anchor instead of or in addition to atissue graft5. For example, the method may include coupling the other tissue anchor to the adjustable loop construct32 and then coupling the tissue anchor to a second bone. The second bone may be a different bone tobone10, or a different segment ofbone10. The adjustable loop construct32 may draw the other tissue anchor towards thebutton100 to fix the second bone in place. The other tissue anchor may be a second cortical button or soft anchor.
• FIGS.4A-4E and5A-5E illustrate examplecortical buttons400 and500 that may have a circular profile. Thesecortical buttons400,500 define an outer boundary that is approximately circular, the outer boundary configured to engage an external bone surface and prevent entrance of thebutton400 and500 into the bone tunnel. Contrary tobuttons100 and200 however,buttons400 and500 are non-passing buttons defined in that they are not configured to have a profile that has a small cross section profile than when deployed to provide the ability to pass it through a bone tunnel of limited diameter. While a larger bone tunnel could be formed to pass these buttons (400,500) therethrough, the tunnel diameter for a circular profile button would also remove the bone external surface that the button would engage once flipped. As such,buttons400 and500 are configured to remain external to the bone tunnels throughout the procedure.Buttons400 and500 may be similar to some embodiments disclosed in commonly owned PCT patent application number PCT/US20/038401 filed Jun. 18, 2020, herein incorporated by reference in its entirety.
• Buttons400 and500 may be preferable for bone locations close to the patient's skin. A portion of thebutton400,500 sits proud of the bone surface which may be easily palpable, these portions configured to have a low and tapered profile to reduce palpability. For example, in ACL repair,buttons400 and500 may engage the tibial side of the repair.Buttons400,500 define a dome shaped top surface with a tapering outer periphery to maintain a reduce profile.Buttons400,500 define a maximum dome thickness T1 that sits proud above the bone external surface that is minimized for reduced palpability. Circular buttons have improved stress distribution around the bone/button interface, which allows them to be thinner (T1) relative tooblong buttons100 and200, for example.
• Button400 includes a post410 (FIG.4D) concentric with itsdome portion420 and extending from alower surface422 ofdome portion420.Lower surface422 may define a flat planar surface for engaging an external surface of the bone.Dome portion420 may include an annularplanar surface421 that lies parallel tolower surface422.Dome portion420 may also include arecess430 for receivingflexible strands30 therein such that theflexible strands30 lie at least partially within therecess430, reducing their palpability.Recess430 is disposed towards the center ofdome portion420 and includes a plurality ofapertures440a,440b,440c,440dtherethrough that provide passage for at least oneflexible strand30 therethrough.Button400 includes fourapertures440a,440b,440c,440d, each defining 360 degree bounded holes. Eachaperture440a,440b,440c,440dmay have the same diameter. The boundaries of allapertures440a,440b,440c,440dmay be disposed entirely withinrecess430.Apertures440a,440b,440c,440dmay extend throughpost410, having an aperture exit at abottom surface412 ofpost410. All fourapertures440a,440b,440c,440dmay be entirely enclosed withinpost410.apertures440a,440b,440c,440dmay be equally spaced from each other.Apertures440a,440b,440c,440dmay be arranged in an approximate square or rectangular arrangement, where each aperture defines an apex of the arrangement.Apertures440a,440b,440c,440dmay define afirst pair440a,440dand asecond pair440b,440c, each pair defining ends of astrand channel442a,442btherebetween.Strand channel442a,442bextends below abottom surface432 ofrecess430. Strandchannels442a,442bat least partially nests a portion of theflexible strand30 therein. Strandchannels442a,442bdefine pulley surfaces that theflexible strand30 may slide along. This may reduce a flexible strand of an adjustable loop construct. Strandchannels442a,442bmay each define convex curved surface along their length, corresponding to the curves of the strand loops (seen best inFIGS.4B and6B).
• Recess430 defines aperiphery434 that may be circular and concentric with dome periphery.Periphery434 may be intersected by a third pair ofapertures445a,445b. The third pair ofapertures445a,445bextend through and along an outer circumferential surface of thepost410.Apertures445a,445beach therefore have a first axial length portion that is fully enclosed, defining a 360 degree bounded hole that is formed entirely by thedome portion420.Apertures445a,445balso include a second axial length portion extending from and continuous with the first axial length portion, that is not fully enclosed, and defines an axial channel (446ashown) bounded by thepost410, best seen inFIG.4D. A first of the third pair ofapertures445ais disposed between thefirst pair440a,440dand radially spaced therefrom. A second of the third pair ofapertures445bis disposed between thesecond pair440b,440cand radially spaced therefrom. The third pair ofapertures445a,445bmay be equal to each other in diameter and both may be larger in diameter thanapertures440a,440b,440c,440d.Button400 is configured to be provided pre-assembled to a flexible strand construct.
• FIGS.5A-5F illustrate another embodiment of abutton500 that may have a circular or slightly oval shapeddome520 and post510 extending therefrom.Button500 may be a non-passing button and may include radial slottedopenings540/543 for receiving a flexible strand therethrough and therefore coupling to a flexible strand construct during the procedure. Similar tobutton400,button500 includes a recessedcentral portion530 for recessing the flexible strand therein, to reduce palpability.Button500 is similar tobutton400, except when noted. For example,button500 includes four channels or pulley surfaces542a,542b,542c,542d. Channels or pulley surfaces542a,542b,542c,542dmay all be orthogonal to each other, forming a square or rectangle around acentral recess post532. Having fourchannels542a,542b,542c,542dgive the user more flexibility while assembling the flexible strand construct. Recessedpost532 may define atop surface533 that is planar and recessed below atop surface524 ofdome portion520.
• Button500 includes a plurality of openings that are slottedopenings540. Slottedopenings540 extend radially from an end of a channel or pulley surface (542a,542b,542c,542d) radially up to and including an outer periphery ofdome portion520.Openings540 define adock portion541 within which the flexible strand (30) nests, with atapered opening portion543 extending radially therefrom.Tapered opening portion543 may be linearly ed to a larger opening at the dome periphery.Dock portion541 extends vertically through a thickness ofdome portion520 and at least partially through a thickness ofpost510.Dock portion541 may extend through and interrupts a circumferential outer surface ofpost510, as seen best inFIGS.5B and5E.Post510 may be configured to fit within a bone tunnel and may be a close or sliding fit with the bone tunnel.Outermost apertures545 define a pair of apertures that may define 360-degree bounded apertures and may be larger in diameter thandock portion541.Button500 may be provided in a variety of sizes. In some larger button sizes, thepost510 may have a larger diameter or width andoutmost apertures545 may intersect withpost510. In an example smaller button size, thepost510 may be entirely medially spaced from theoutermost holes545 and therefore thepost510 andholes545 do not intersect.
• FIGS.6A and6B illustrate a system including abutton400 andflexible strand630.Flexible strand630 may be provided assembled tobutton400 and may include at least onelocking passage638 therealong.FIG.6B shows two loop ends620 extending through the two pair ofapertures440a,440b,440c,440dand each aperture including a single length ofstrand630 therethrough. Tension will nest theloops620 within the correspondingchannels442a,442b, that may be contoured, defining convex curved surfaces for engagingloops620.Limbs625a,625bmay extend through the third pair onapertures445a,445b. Tension on thelimbs625a,625bmay slide theloops620 through corresponding channels and reduce the overall loop lengths. Stated in another way, tension on thelimbs625a,625bmay draw thelocking passage638 towards thebutton400.
• In a similar manner shown inFIGS.6A-6B,button500 may be provided operatively coupled to an adjustable loop formed with aflexible strand630, in a similar manner to that shown inFIGS.6A-6B. For all inside techniques the surgeon may detach or disassemble at least one of theloops620 from thebutton500 viaslots540.Button500 may be completely removed fromflexible strand630, and at least oneloop620 andlimb625amay be passed through the joint and then re-assembled with the button500 (via pulleys) to create the fully assembled loops once again.
Adjustable Loop Embodiments
• FIG.7 illustrates an adjustable loop construct700 that may include two lockingpassages710a,710b, and may be assembled or partially assembled to an anchor, such as acortical button750. Adjustable loop construct700 may be formed from aflexible strand30. Adjustable loop construct700 may be preassembled to at least one side ofbutton750, together defining an adjustablesuspensory fixation system706. Adjustable loop construct700 may be formed from a single length of aflexible strand30.Button750 may be any button disclosed herein, or other cortical buttons known in the art such as for example, buttons disclosed in commonly owned PCT patent application number PCT/US20/038401 filed Jun. 18, 2020, or commonly owned U.S. Pat. No. 10,383,617 both references incorporated by reference in their entirety.
• Adjustable loop construct700 may define a portion of an adjustablesuspensory fixation system706 for ligament reconstruction or repair. During tissue repair,saddle end704 may couple to a body, the body being at least one of, but not limited to a tissue component or a surgical component; the tissue component being for example a ligament or graft; the surgical component may be a tissue anchor, or another flexible strand. For example, the adjustablesuspensory fixation system706 may couple a first bone to a second bone and may have another tissue anchor operatively coupled to saddle end704 (not shown here). Body may be coupled toloop saddle end704 between the two lockingpassages710a,710b.
• Adjustable loop construct700 may be formed byflexible strand30 that is braided suture, braided to be hollow defining an elongate passage therealong. Adjustable loop construct700first end702 may be assembled tobutton750 and anopposite saddle end704 may be coupled to a body as defined herein. Adjustable loop construct700 includes two lockingpassages710a,710bspaced away from thesaddle end704. Relative to theconstruct32 shown in at leastFIG.3A, that includes asingle locking passage38, two lockingpassages710a,710bmay provide similar knotless locking strengths (withstand similar physiological cyclic loading), but two locking passages or split locking passages may offer several advantages. For example, this configuration of lockingpassages710a,710bmay allow theconstruct700 to be reduced in loop perimeter with lower forces or tensions on ends705a,705brelative to a construct with a single locking passage. This is a result of the lockingpassages710a,710bbeing approximately linear (not curved or bent) and approximately parallel to the reduction force direction (F) on ends705a,705b. In comparison, lockingpassage38 is curved as it loops around the construct end. During reduction,strands30 slide through the corresponding locking passage. Maintaining a linear locking passage allows thestrands30 to slide linearly and reduce strand cinching from a kink or curve along the locking passage. Furthermore, coupling asaddle end704 free of a locking passage to a body may be easier. The inventors have found that the inherent increased outer diameter of a locking passage may add significant force and/or tissue tearing while threading through the body (as defined herein). Larger tunnel opening sizes may be required through tissue anchors for example, to fit the locking passage. In the case of soft tissue grafts, larger needles and/or higher forces may be needed to thread the locking passage through the soft tissue.
• The inventors have also found that the spacing length (SL) or linear distance along thestrand30 between the two lockingpassages710a,710bpreferably has an upper length limit. Consider that when reducing theadjustable loop construct706, the shortest the loop construct may reduce to, or a minimum reduced loop length is limited by the fixed length portions of the adjustable loop construct. These include at least the lengths of the twopassages710a,710band spacing length SL between the twopassage710a,710b. Depending on the length of tissue or graft, or anatomy of the repair, significant reduction may be preferable. Depending on the length of tissue or graft, or anatomy of the repair, a short final reduction length may be preferable. Therefore, the shorter the two lockingcradles710a,710band spacing length SL are, the smaller the adjustable loop construct can become, with reduction. A shorter length of the lockingpassages710a,170band spacing length SL may provide an adjustable loop construct that accommodates a wider range of graft or tissue configurations. Lockingpassages710a,710bhowever require a minimum length to securely cinch and knotlessly lock theadjustable loop706. The lockingpassages710a,710btherefore define a length of the adjustable loop construct700 that is not adjustable and provides sufficient locking forces on theadjustable suture loop700, capable of withstanding the physiological loading. This length may depend on the flexible strand material and properties. In some example embodiments, each lockingpassage710a,710bmay be between 0.5-1.5 inches long, and may more preferably be approximately 0.75 inches long.
• The spacing SL is preferably also short to avoid adding unnecessary length to a minimum reduced loop length of theadjustable suture loop700. Spacing length SL is preferably sufficient to split the two lockingpassages710a,710bto reduce adjustable loop reduction forces F. The spacing length SL between the two locking passages as measured along thestrand30 linearly (seeFIG.8A) between the two lockingpassages710a,710bmay be between 0.10-0.5 inches, and may, in some procedures be approximately 0.25 inches.
• FIG.8A-8C demonstrate the steps to forming theconstruct700. Beginning withFIG.8A, a length of aflexible strand30 is shown. Locations of lockingpassages710a,710bare shown as enlarged or dilated portions for clarity of discussion. However, as provided, these locations may be similar in diameter and shape to the remaining length of thestrand30 and the act of spicing thestrand30 and extending thestrand30 through itself may dilate that portion of thestrand30. A snare loop (not shown) may extend alongpassages710a,710b. A dilating means (not shown) may be first extended through passage locations.
• Turning now toFIG.8B, end705bmay be extend into and along thestrand30 at alocking passage location710band exit thepassage710bfor a length (approximately SL) before extending into and alongstrand30 at lockingpassage location710a. This forms afirst eyesplice loop708bandlimb705b. The length SL between the two lockingpassages710a,710bmay be selected, depending on the procedure or application. For example, if thesaddle end704 is configured to couple to a graft, the saddle length SL may be long enough the wrap around the graft width, with the lockingpassages710a,710bdisposed along a side of the graft. As a second example, if thesaddle end704 is configured to couple to a tissue anchor, the length SL may be long enough to couple to the anchor, placing the lockingpassages710a,710boutside of the tissue anchor, and will depend on the anchor configuration. While forming thisfirst eyesplice loop708b, the loop may be threaded through apertures of a button, such as forexample apertures110a,110binFIG.1A.First eyesplice loop708bmay therefore directly coupled to abutton anchor750. This may assemble theconstruct700 with a button. As showneyesplice loop708bis short, for simplicity of the figure, however length ofloop708bmay be of any length.
• FIG.8C shows formation of asecond eyesplice loop708a.Limb end705amay extend into and along thestrand30 at lockingpassage710afirst, forming thesecond eyesplice loop708b.Limb end705amay than extend for a length alongsaddle end704 before extending into and alongstrand30 at lockingpassage710b.Second eyesplice loop708amay also thread through apertures of a button, such as forexample button400. This assembles bothloops708a,708bto a button. In other embodiments, at least one of theloops708a,708bmay define a free looped end, and be looped over and through slotted openings of the button during the procedure.Buttons100,200 or500 show slotted openings that allow for selective assembly with at least one of theeyesplice loops708a,708bfrom the button. On other examples, at least one loop and limb (708a,708b,705a,705b) may be operatively coupled to a threading member such as a shaft, rod or needle (example passing construct300 shown in at leastFIG.3A). Threading member may be configured to insert a loop and/or limb of theconstruct700 through a body such as a tissue, a graft or a tissue anchor for example.
• In thisconstruct700, each lockingpassage710a,710bincludes two lengths ofstrand30 extending therethrough. The two lengths ofstrand30 cross over each other to exit from opposite ends of each lockingpassage710a,701b. In other embodiments, each limb may only extend through onelocking passage710a,710b. For example,limb705bmay extend throughpassage710bonly to formeyesplice loop708a. The distance between to the twodiscrete locking passages710a,710bmay be sufficient to suspend a graft thereover, or extend through a thickness of tissue, or through an anchor.Saddle end704 may include three strand lengths ofstrand30, two of which are slideable and one single strand which is static or fixed (non slideable) and extends directly from, and is continuously braided with both lockingpassages710a,710b.
• FIG.9A illustrates another adjustable loop construct900 that may form a plurality of adjustable loops and may include two lockingpassages910a,910b. Adjustable loop construct900 may define an adjustable suspensory fixation device for ligament reconstruction or repair. In other examples, construct800 may define an adjustable coupling means between a first and second bone and may have a tissue anchor operatively coupled to a portion of the construct900 (not shown here).
• Adjustable loop construct900 may be formed by a braided suture that may be hollow to define an elongate passage therealong. The two lockingpassages910a,910bare formed by splicing the suture through itself, which under tension forms a knotless locking mechanism and prevents the loop from expanding. The adjustable loop construct definesfirst end902 that may be assembled to abutton950 and anopposite saddle end904. Adjustable loop construct900 may have locking forces with reduced loop reduction forces similar to construct700.
• The steps of formingconstruct900 may begin withstrand30, similar to that shown inFIG.8A with similar locations and philosophies for locking passages. However, compared toFIG.8B, the loops are formed differently. Shown inFIG.9B, forming theadjustable construct900 may include extendingend905bthrough an aperture of a button950 (shown inFIG.9A) and then through thestrand30 at location identified as910afirst, preferably on a sideadjacent end905aand then exit thepassage910aadjacent saddle904.End905bthen extends alongsaddle904 for a length before extending alongstrand30 at lockingpassage location910b. This forms afirst loop908bandlimb905b. While forming thisloop908b, the loop may be threaded through apertures of a button, such as forexample apertures110a,110binFIG.1A. Another button example is disclosed in commonly owned U.S. Pat. No. 10,383,617 both references incorporated by reference in its entirety. Each aperture preferably provides passage for a single strand of suture therethrough. This assembles theconstruct900 with a button. Asecond loop908amay be formed in a similar manner to thefirst loop908band is shown inFIG.9C.Limb end905aextends through thestrand30 at lockingpassage910bfirst then across thesaddle904 before extending alongstrand30 at lockingpassage710a.
• FIG.10 illustrates anotherexample construct1000, that may be assembled with abutton1050 and may include fourlocking passages1010a,1010b,1010c,1010d.
• In some embodiments, adjustable loop construct700 may be provided assembled to abutton750 in a fully assembled configuration (also termed a closed loop configuration). Unlike the construct illustrated in3A-3D, bothloops708a,708bmay be preassembled tobutton750. Button may include four 360 degree)(° bounded holes and therefore disassembly of aloop708a,708bmay not be available, without deconstruction of the adjustable loop. In some embodiments, when provided in a closed loop configuration, adjustable loop construct700 may include a passingconstruct1450 coupled to thesaddle end704, as illustrated inFIG.14. The passingconstruct1450 is configured to draw the adjustable loop construct700 through a tissue or graft.
• Passingconstruct1450 may include aloop1455 formed of a flexible strand such as a wire or suture.Loop1455 may be coupled to athreading member1460 andloop1455 may having a fixed length (non-adjustable).Threading member1460 may be a rigid needle that pierces the tissue or graft.Threading member1460 may be configured to pass through apertures of another tissue anchor (not shown) or prepared tunnels through bone.Threading member1460 may be configured to pierce a tissue or graft and draw theloop1455 followed by thesaddle end704 of adjustable loop construct700 therethrough.
• Loop1455 may originate as a length of suture or wire, with two terminal ends that are swaged or crimped to threadingmember1460, to form theloop1455.Loop1455 may be formed of a flexible strand that is different or separately formed fromflexible strand30. Passingconstruct1450 may be coupled to the three strand lengths of thesaddle end704 with a complex loop. The complex loop may be configured to sequentially draw the three strand lengths through the tissue. Sequentially drawing the strand lengths of thesaddle end704 may reduce tissue damage or deformation, and reduce forces required to draw thesaddle end704 through the tissue or graft. This passingconstruct1450 may couple thesaddle end704 to the tissue or graft. The complex loop may be configured to limit sliding of the passingconstruct1450 along theadjustable loop construct700. The complex loop may help to control the three length strands and maintains them in close approximation as they slide relative to each other, as explained further herein.
• Loop1455 may form a complex loop around the saddle end, such as a figure-of-eight loop as illustrated in part inFIG.15.FIG.15 illustrates afirst locking passage710a, with the three strand lengths extending therefrom.Strand length730adefines a static strand, in that it is directly coupled to and extends from both lockingpassages710a,710b. While reducing theadjustable loop construct700,strand length730adoes not slide.Strand length730amay be continuously braided with lockingpassages710a,710band therefore does not extend through and slide through lockingpassages710a,710b. Strandlengths730b,730care dynamic strands, eachstrand730b,730ccontinuous with alimb705a,705b. Drawing onlimbs705a,705bslidesdynamic strand lengths730b,730cthrough thepassages710a,710bto reduce the adjustable loop perimeter.
• Loop1455 may form afirst loop1455aof the figure-of-eight loop around thestatic strand730a, andsecond loop1455bof the figure-of-eight loop may wrap around bothdynamic strands730b,730c. The figure-of-eight configuration may limit sliding of the passingconstruct1450 along and around theadjustable loop construct700. Sliding off-center may need correction by the user during stitching. Thefirst loop1455aof the figure-of-eight is limited to sliding only along thestatic strand730a, and the extent of sliding is bounded by thelocking passage710a,710b. Limiting sliding may avoid asymmetry as the adjustable loop construct700 is threaded through a tissue or graft. The figure-of-eight loop configuration is configured to maintain the passingconstruct1450 between the two lockingpassages710a,710b. Without the figure-of-eight loop formation,loop1455 may slide over one of the lockingpassages710a,710band draw that locking passage first into and through a graft or tissue. As explained earlier, this may increase the forces required to couple the adjustable loop construct700 to the graft of tissue. In addition, if theloop1455 was not a figure-of-eight loop and wrapped around just thestatic strand length730a, thedynamic strand lengths730b,730cmay trail too far behind when passing through tissue/graft, creating confusion during stitching and uneven adjustment of theconstruct700. The figure-of-eight loop may first pass thedynamic strand lengths730b,730cthrough a graft, followed by thestatic strand length730a, followed by the two lockingpassages710a,710b. Thesecond loop1455bis configured to contain the two dynamic strand lengths in close apposition while passing thesaddle end704 through the tissue/graft, which may reduce confusion during stitching through tissue or graft.Loop1455 is coupled to the adjustable loop construct700 such that it maintains a substantially central location of the passingconstruct1450 along the adjustable suture loop700 (limits sliding of the passingconstruct1450 along the saddle portion704), while allowing thedynamic strand lengths730b,730cto slide without inhibiting reduction of theadjustable loop construct700. The passingsuture loop1455 is coupled to the adjustable loop construct700 to manage effective passing of the threestrand lengths730a,730b,730cthrough tissue, keeping them aligned relative to each other.
• In another configuration,loop1455 may form a complex loop in the form of a luggage tag loop, around all threestrands730a,730b,730c. However, this may cinch around the moving (dynamic)strands730b,730cand consequently increases the loop reduction force. A further embodiment is shown inFIG.16A-16B whereinloop1455 forms a complex loop in the form of a split luggage tag loop including afirst loop1455aaaround thestatic strand730a. Thesecond loop1455bbsplits to loop around both sides of thedynamic strands730b,730c(seen best inFIG.16B). This loop however requires a more complicated assembly.
Method of Attaching an Adjustable Loop Construct
• A method of attaching anadjustable loop construct1700 to agraft1650 is illustrated inFIGS.17A-17J.Adjustable loop construct1700 may be similar to adjustable loop constructs (32,700,900,1000) disclosed herein and may be linked to a passing construct1750 at a linkingend1704 of theadjustable loop construct1700. Passing construct may be coupled to a linkingend1704 with a complex loop, as disclosed herein. For example, adjustable loop construct may be construct700 linked to passingconstruct1450 at asaddle end704 with a figure-of-eight loop. However, this method is not limited to construct700 and construct1450. The method disclosed couples anadjustable loop construct1700 to agraft1650, such that the final stitched graft includes both anadjustable loop construct1700 and aflexible loop1755 of a passing construct1750 stitched therethrough, theflexible loop1755 linked to, but separately formed fromadjustable loop construct1700. In the final stitched graft, theflexible loop1755 may define stitches that axially overlap the adjustable loop construct stitches.FIGS.17A-17J shows a simplified form of anadjustable loop construct1700, omitting elements such as but not limited to locking passages (such as but not limited to lockingpassages710a,710b) and the individual adjustable loops (such as but not limited toloops708a,708b) and a linking end1704 (such as but not limited to saddle end704). These details are omitted from the figures to simplify understanding of the figures and thereby method. In addition, this method may couple any of the adjustable loop constructs disclosed herein, or others known in the art, with differing locking passages and adjustable loop configurations to a graft in this manner.
• Starting withFIG.17A, the method may include obtaining and/or obtaining agraft1650.Graft1650 may be an elongate body, defining atop side1655,bottom side1675, and two opposingends1660,1670. One of the two opposing ends (1670) may be clamped to stabilize thegraft1650 during stitching, and therefore may be defined as a clampedend1670. The other of the two opposing ends may be thefree end1660.Free end1660 may be inserted first into a prepared tissue tunnel and may be directly coupled to both the adjustable loop construct and passing construct loop.Free end1660 may be tapered or bulletized using a scalpel or scissors for easier threading through a prepared bone tunnel.Graft1650 may be a single solid body, typically harvested from the Quad Tendon.Graft1650 may include wispy ends.Graft1650 may be provided as a plurality of elongate strands, typical when harvesting from the hamstring for example.Graft1650 may be folded over itself to form a target thickness ofgraft1650.
• Now turning toFIG.17B showing a side view of thegraft1650, the method of attaching may include forming and/or obtaining anadjustable loop construct1700 that may be assembled to acortical button1715 at one end and assembled to aflexible loop1755 of a passing construct at the other end (hereinafter linked end1704). Theflexible loop1755 may be operatively coupled to athreading member1760 such as a needle defining, together, the passing construct1750.Threading member1760 may pierce thegraft top surface1655 and draw theflexible loop1755 from thegraft top surface1655 through the thickness ofgraft1650 to the lowerexternal surface1675, at a first location (1), defining a first pass through thegraft1650. First location (1) may be about 1.5 cm-2 cm from terminal edge offree end1660. In some example methods,flexible loop1755 may form a complex loop and couple to a plurality of strands (730a,730b,730c) along the linkedend1704 that may be similar to saddleend704. Complex loop is not shown inFIGS.17B-17J but may be seen in at leastFIG.15 and may be configured to stagger entrance of the plurality of strands (730a,730b,730c) through thegraft1650 during this first pass. Complex loop may also maintain a location of the flexible loop within a target zone along theadjustable loop construct1700. The first pass may be complete when passing construct1750 is drawn completely throughgraft1650, until the entire passing construct1750 is external to thegraft1650 and theadjustable loop construct1700 extends throughgraft1650 and from both thetop surface1655 and bottom surface1675 (FIG.17C). The conclusion of the first pass places thecortical button1715 adjacent thefree end1660 andtop surface1655 and the linkedend1704 adjacent the bottom surface1675 (FIG.17C). This may also preferably place any locking passages external to thegraft1650 adjacent thebottom side1675.Adjustable loop construct1700 may include twolimbs1705a,1705bwrapped around a carrying card ortool1725 for management thereof. First pass may extend through thegraft1650 at an angle that is neither inclined relative to the longitudinal axis (Y-Y), and therefore neither parallel to nor orthogonal to longitudinal axis (Y-Y) of thegraft1650. Angle may be between 30-60 degrees relative to the longitudinal axis. First pass may extend along and intersect the longitudinal axis. First pass, and all subsequent passes may extend through a midline of thegraft1650, as best possible, given the nature of soft tissue grafts.
• The adjustable loop construct linkedend1704 may then be spread to wrap around both external side surfaces ofgraft1650 and flip over thefree end1660, thebutton1715 and card ortool1725 to the top surface1655 (FIG.17D). This may place the linkedend1704 between the clampedend1670 and the first location (1). Theadjustable loop construct1700 may then be reduced via tension on thelimbs1705a,1705b(which may be coupled to a card or tool1725).Adjustable loop construct1700 may be reduced such that the linkedend1704 is circumferentially wrapped around the external surfaces of graft1650 (FIG.17E) andbutton1715 is adjacentfree end1660. While flipping the linkedend1704, theflexible loop1755 of passing construct1750 may be maintained between any locking passages, via the complex loop such as the figure-of-eight loop through the linkedend1704.Adjustable loop construct1700 may be reduced by drawing the flexible strand through any locking passages of theadjustable loop construct1700, such that the locking passages circumferentially wrapped around the external surfaces of graft1650 (FIG.17E). Reducing theconstruct1700 may place the locking passages substantially external to the graft and not within the graft, which may cinch the locking passages and frustrate loop reduction.
• Turning now toFIG.17F, threadingmember1760 may be passed again (second pass) from thegraft top surface1655 to thebottom surface1675, at a second location (2), directly adjacent to linked end1704 (FIG.17F). This locks the location of linkedend1704 along thegraft1650 and prevents the linkedend1704 from sliding along thegraft1650. Second location (2) may be approximately coincident with linkedend1704, and between the clampedend1670 and first location (1). Theadjustable loop construct1700 in now fixedly attached to thegraft1650. The second pass may be orthogonal to the graft longitudinal axis (Y-Y) and may define the furthest-most pass from thefree end1660. At the end of the second pass a portion offlexible loop1755 may extend through thegraft1650. At the end of the second pass (FIG.17G) afirst loop1755aof a complex loop offlexible loop1755 may be retained ontop surface1655 whilesecond loop1755bmay extend throughgraft1650.
• Theflexible loop1755 may now form a running whipstitch alonggraft1650, progressively moving towards thefree end1660, the running whipstitch preferably including at least two whipstitch passes (a third and a fourth pass of the attachment method) through thegraft1650. This running whipstitch forms a plurality of axially spaced circumferential wraps around the graftfree end1660. Tensioning these plurality of axially spaced circumferential wraps forms the graftfree end1660 into a more cylindrical shape, for easier passing through the prepared bone tunnel. Tensioning on these whipstitches may further taper the graftfree end1660, for easier passing through the prepared bone tunnel. This running whipstitch may include at least two passes, and acts to mitigate attachment rip-stopping (adjustable loop construct1700 andflexible loop1755 from cheese-wiring out of graft). Whipstitches run progressively towards thefree end1660. Whipstitches may be formed by looping the flexible loop1755 (which may besecond loop1755b) around from thebottom surface1675 andend1660 to place the threadingmember1760 on the top surface (FIG.17H andFIG.17I).Threading member1760 may then passe from thetop surface1655 to thebottom surface1675 again. This may be at a location (3) betweenfree end1660 and location (1). This may circumferentially wrap the flexible loop1755 (1755b) around thegraft1650, over and across theadjustable loop1700 that is wrapped around the graft external side surfaces and the linkedend1704.
• The steps shown inFIG.17H-17I may be repeated to form a second whipstitch of the running whipstitch, shown inFIG.17J.Flexible loop1755 may be wrapped around thegraft1650 and over thefree end1660 to place the threadingmember1760 on thetop surface1655.Threading member1760 may then pierce the graft and pass through from thetop surface1655 to thebottom surface1675 at a location between location (4) andfree end1660. This may be repeated until the whipstitch passes reach theterminal edge1661 of thefree end1660.Loop1755 may then be tied in a knot and cinched tightly to further taper taperedfree end1660. The threadingmember1760 may then be removed, leaving a trimmedloop1755′ available (FIG.17J).
• Graft1650 coupled toadjustable loop construct1700 and trimmedloop1755′ (trimmed from threading member1760) may then be threaded through a prepared bone tunnel (not shown). Trimmedloop1755′ (FIG.17J) may be sufficiently long to couple to a tool to drawgraft1650 into and along prepared bone tunnel. Trimmedloop1755′ therefore has a length, as provided or obtained sufficient to form at least two whipstitch passes through a graft, leaving sufficient length to be drawn along prepared bone tunnel. Drawing on the trimmedloop1755′ is preferable over drawing with theadjustable construct1700 to avoid the graftfree end1660 from folding over itself while sliding through prepared bone tunnel. Drawing on theadjustable construct1700 only may form a fold adjacent second location (2).
• Turning now to a more specific example, a method of attaching may include forming or obtaining adjustable loop construct700 assembled with acortical button750 at one end and coupled to a passingconstruct1450 atsaddle end704.Needle1460 may pierce thegraft top surface1655 and draw theloop1455 of passingconstruct1450 from thegraft top surface1655 through the thickness ofgraft1650 to the lowerexternal surface1675, at a first location (1), defining a first pass. First location may be about 1.5 cm-2 cm fromterminal edge1661 offree end1660. In some example methods,flexible loop1455 may form a complex loop and couple to a plurality of strands (730a,730b,730c) along thesaddle end704. Complex loop may be configured to stagger entrance of the plurality of strands (730a,730b,730c) through thegraft1650 during this first pass. Complex loop may be a figure-of eight loop, with afirst loop1455alooped aboutstatic strand730a, and asecond loop1455blooped aroundstrands730b,730c. The first pass may be complete when passingconstruct1450 is drawn completely throughgraft1650, until theentire passing construct1450 is external to thegraft1650 and the adjustable loop construct700 extends throughgraft1650 and from both thetop surface1655 andbottom surface1675. The conclusion of the first pass places thecortical button750 adjacent thetop surface1655 and thesaddle end704 adjacent thebottom surface1675. Adjustable loop construct700 may include two limbs (705a,705b) wrapped around a carrying card ortool1725 for management thereof. First pass may extend through thegraft1655 at an angle that is inclined relative to a longitudinal axis (L-L) of thegraft1650. Angle may be between 30-60 degrees relative to the longitudinal axis. First pass may extend along and intersect the longitudinal axis. First pass may be oriented substantially along a midline of thegraft1650, as best possible, given the nature of soft tissue grafts.
• Saddle end704 may then be spread to wrap around both sides ofgraft1650 and flip over thefree end1660, thebutton750 and card ortool1725 to thetop surface1655. This may place thesaddle end704 between the clamped end and the first location (1) on thetop side1655. The adjustable loop construct700 may then be reduced via tension on thelimbs705a,705b(which may be coupled to a card ortool1725. Adjustable loop construct700 may be reduced such that thesaddle end704 is circumferentially wrapped around thegraft1650 andbutton750 is adjacentfree end1660. While flipping thesaddle end704, the passingconstruct1450 may be maintained between locking passages (710a,710b), via the complex loop such as the figure-of-eight loop through thesaddle end704.
• Needle1460 may be passed again (second pass) from thegraft top surface1655 to thebottom surface1675, at a second location (2), directly adjacent to saddleend704. This locks the location ofsaddle end704 along thegraft1650 and prevents thesaddle end704 from sliding along thegraft1650. Second location (2) may be approximately coincident withsaddle end704, and between the clampedend1670 and first insertion location (1). The adjustable loop construct700 in now fixedly attached to thegraft1650. The second pass may be approximately orthogonal to the graft longitudinal axis and may define the furthest-most pass from thefree end1660. At the end of the second pass a portion offlexible loop1455 may extend through thegraft1650. At the end of the second pass afirst loop1455aof the complex loop offlexible loop1455 may be retained ontop surface1655 whilesecond loop1455bmay extend throughgraft1650.
• Theflexible loop1455 may now form a running whipstitch that progressively stitches towards thefree end1660, the running whipstitch preferably including at least two whipstitch passes (a third and a fourth pass of the attachment method) through thegraft1650. This running whipstitch forms a plurality of axially spaced circumferential wraps around the graftfree end1660. Tensioning these plurality of axially spaced circumferential wraps forms the graftfree end1660 into a more cylindrical shape, for easier passing through the prepared bone tunnel. Tensioning on these whipstitches may further taper the graftfree end1660, for easier passing through the prepared bone tunnel. This running whipstitch may include at least two passes, and acts to mitigate attachment rip-stopping (adjustable loop construct700 andflexible loop1455 from cheese-wiring out of graft). Whipstitches run progressively towards thefree end1660. Whipstitches may be formed by looping thesecond loop1455baround from thebottom surface1675 andgraft end1660 to place theneedle1460 on the top surface.Needle1460 then passes through from thetop surface1655 to thebottom surface1675. This may be at a location (3) betweenfree end1660 and insertion location (1). This may circumferentially wrap thesecond loop1455baround thegraft1650, over and across the adjustableloop saddle end704. This may circumferentially wrap thesecond loop1455baround thegraft1650, over and across the lockingpassages710a,710bsuch that upon tensioning this, the lockingpassages710a,710bmay no longer be adjustable.
• A second whipstitch may be formed by looping thesecond loop1455bagain around from thebottom surface1675 andend1660 to place theneedle1460 on the top surface.Needle1460 then passes again through from thetop surface1655 to thebottom surface1675. This may be at a location betweenfree end1660 and insertion location (3). This may be repeated until the whipstitch passes reach the terminal edge of thefree end1660.Second loop1455bmay then be tied in aknot1810 and cinched tightly to further taper taperedfree end1660. Theneedle1460 may then be removed, leaving a length ofsecond loop1455bavailable (that may no longer be a loop.)Graft1650 coupled toadjustable loop construct700 andsecond loop1455b′ (trimmed from needle1460) may then be threaded through a prepared bone tunnel (not shown).
• FIG.18A illustrates a top down view of the adjustable loop construct700 stitched throughgraft1650, after the first pass and before the second pass, similar to arrangement shown inFIG.17E.FIG.18B illustrates a top down view of theadjustable loop construct700 andflexible loop1455 stitched throughgraft1650, in the final stitched configuration.FIG.18B also shows the circumferential wraps and tapering of thefree end1660. Knot1855 is shown insecond loop1455bwith trimmedsecond loop1455b′ extending therefrom.
Reduction Bar
• FIGS.11A-13D illustrate various features of areduction bar1100 and an associated method of use.Reduction bar1100 may provide a plurality of functions during a tissue repair.Reduction bar1100 may be assembled to an adjustable suspensory fixation system and used as a handle or tool that applies tension to adjustable loops of the fixation system to place the graft in the target location.Reduction bar1100 may also be provided or obtained with the suspensory fixation system preassembled thereto and therefore could equally be called a fixation system storage tool.
• Suspensory fixation systems, such assystem280 shown inFIG.3A include multiple loops of aflexible strand30, which if provided in loose form may be difficult to keep track of and prone to strand entanglement or errors while coupling to the graft.Reduction bar1100 may include retaining and storing means including cavities, slots, cleats, channels and spools arranged along thereduction bar1100, for housing or retaining portions of the suspensory fixation system. Other example fixation systems that may be assembled to thisreduction bar1100, are disclosed herein, as well as in commonly owned PCT patent application number PCT/US20/038401 filed Jun. 18, 2020, titled “METHODS AND DEVICES FOR TISSUE GRAFT FIXATION” commonly owned and herein incorporated by reference in its entirety.
• These storing means may retain and manage components of the suspensory fixation system such that they are on an external surface ofbar1100 and selectively removeable from thebar1100 in stages, according to the stages of operation of the tissue repair.Reduction Bar1100 may therefore not only store a suspensory fixation system but also arrange the suspensory fixation system to guide the staged release thereof, according to the preferred stages of the procedure.
• More specifically, these storing means may arrange components of a suspension fixation system that may include an adjustable loop construct (32), passing construct (300) and tissue anchor (100,200) around thereduction bar1100 such that release of these components is staged to improve management of the suspensory fixation system during the tissue repair and limit entanglements and confusion. With reference toFIGS.3A-3E, these storing means may arrange theadjustable loop construct32, passingconstruct300 andtissue anchor100,200 around thereduction bar1100 such that the passingconstruct300 may be released first, the passingconstruct300 preassembled to thefree limb33band freeadjustable loop35b. Thefree limb33band freeadjustable loop35bmay then be removed from thebar1100. The remains of thesuspensory fixation system280 may be left retained by thebar1100, while the passingconstruct300,free limb33band freeadjustable loop35bare coupled to the graft (FIG.3A).
• Additionally, thereduction bar1100 may operate as a tool that guides closing of an open adjustable loop construct such assuspensory fixation system280. For example, the anchor (100,200) may be provided stored within thebar1100 in an orientation that exposes the slottedapertures120a,120b(FIG.11C-11E). The slottedapertures120a,120bmay align with a guide surface of thereduction bar1100, to align and guide the freeadjustable loop35binto the slottedapertures120a,120b.
• Additionally, thereduction bar1100 may operate as a handle while reducing theadjustable loop construct32, and thereby alleviate forces on the surgeon's hand.Reduction bar1100 may include a means of operatively coupling to looped limb ends33a,33bof the adjustable loop construct32 for example, placing thesuspensory fixation system280 in a reducing configuration. Thebar1100 may then be rocked and rotated while applying tension to theends33a,33b, to reduce the adjustable loop construct size and thereby draw the tissue, graft, or tissue anchor towards the tissue anchor (100,200).
• As such,reduction bar1100 is a multi-functional handle body, configured to store a suspensory fixation system that may include at least one of an adjustable loop construct, a tissue anchor, and a passing construct.Reduction bar1100 may also provide a means of guiding assembly of an open loop adjustable construct to the tissue anchor.Reduction bar1100 may be provided assembled with the suspensory fixation system, to stage the release of components of the system in accordance with the tissue repair.Reduction bar1100 may also reassemble with the adjustable loop construct, in a different arrangement to the preassembled arrangement to reduce/adjust the adjustable loop construct.
• FIGS.11A-11E illustrate various features ofreduction bar1100, with a suspension fixation system removed. Starting withFIGS.11A and11B,reduction bar1100 may generally be a unibody, sized to fit within a surgeon's hand and be comfortable while tensioning and reducing the adjustable loop construct.Reduction bar1100 may define an elongate body, defining a longitudinal axis X-X and an oval or oblong cross section.Bar1100 may have a more bulbous, larger cross section along alower side1117, configured to sit within a user's curled fingers. Barlower side1117 may also define an arced or convexcurved surface1110, curved along the longitudinal axis X-X such that thehandle1100 has thickest cross section close to a midline M-M ofhandle1100. Elongate convexcurved surface1110 and bulbouslower side1117 together are shaped to rests within a surgeon's fingers while applying tension on the adjustable loop construct.
• Bar1100 has amedial length portion1111, withcircumferential spools1113a,1113bat either end thereof.Bar1100 includes a firstlateral end1114 extending fromspool1113athat has a firstlateral end surface1124 that may be planar. A second opposinglateral end1116 extends fromspool1113b. Each spool may be intersected (one each) by anotch1123a,1123b. Eachnotch1123a,1123bmay be curved and may be an “L” shape, or reverse “L” shape. Eachnotch1123a,1123bextends through a thickness of thebar1100, best shown inFIG.11E.Bar End1114 may be different to barend1116.Bar end1114 may extend further along the longitudinal axis X-X from themedial portion1111. Therefore bar1100 may be an asymmetrical body about a plane through the midline M-M.Bar end1114 is sized to include aslot1150 for housing a portion of a tissue anchor.Bar end1114 includeschannel1155 extending fromslot1150 for housing a portion a flexible strand coupled to the anchor.
• Bar1100 may define a plurality of circumferentially extendingribs1112 that may add structural integrity to thebar1100 while accommodating manufacturing processes and reducing material use. At least some of theribs1112 may be non-continuous, defining gaps along themedial length portion1111, such asrelief1120,channel1130 andretention channel1140. These gaps may provide at least some of the storing means for portions of the suspensory fixation system including the adjustable loop construct and passing construct, disclosed in more detail hereafter.
• FIGS.11C-11E illustrates various views ofbar1100 with an example button assembled thereto.FIG.11C illustrates the back side ofbar1100, that may be free of any retaining slots or channels along themedian portion1111.Slot1150 is configured to house a portion of button, such asbutton100,200.FIG.11D illustratesbutton100,200 housed withinslot1150. Thechannel1155 is continuous with and extends from theslot1150 and is also continuous withspool1113a, such that a portion of the adjustable loop construct (shown in later figures) coupled to the button may extend from within theslot1150, alongchannel1155 and into and aroundspool1113a(FIG.12C).
• Slot1150 may housebutton100 to expose a portion thereof includinglateral openings121a,121b, seen best inFIG.11E.Planar surface1124 may be orientated at a non-orthogonal angle to longitudinal axis X-X and may provide a guiding surface when assembling a freeadjustable loop end35bof an open adjustable loop construct to cortical button (a small portion of freeadjustable loop end35bis shown adjacent surface1124) As such sliding freeadjustable loop end35balong surface1124 (see arrow) may thread theadjustable loop end35bthrough thelateral slots121a,121band into the slottedapertures120a,120bto close the open adjustable loop construct32 (FIG.3C,3D). This preferably occurs after threading thefree loop end35bthrough a graft, as disclosed herein.
• FIG.12A illustrates thesuspension fixation system280. This includes a button100 (illustrated in simpler form), andadjustable loop construct32. For understanding of assembly of thesuspension fixation system280 to thereduction bar1100,FIG.12A illustrates an imaginary split of thesuspension fixation system280 intoportions1200aand1200b.Portion1200a, as indicated on the figure may include the passingconstruct300, (threadingelement305 and passing loop310) the freeadjustable loop end35b, the free loopedend33b, the lockingpassage38.Portion1200amay also include some of theflexible strand30 that forms the portion of the assembled loop end35athat extends directly between the lockingpassage38 andanchor100.Portion1200amay also include allstrands30 that extend directly betweenanchor100 andpassage38. As such is may include strand length portions of first loopedend33aandlimb35bthat are directly between thebutton100 and lockingpassage38.Portion1200bas indicated on the figure may include theanchor100, assembled to the assembled loop end35aand the loopedend33a.
• FIGS.12B and12C illustrate (in combination) how thebar1100 and a suspensory fixation system may be provided or obtained in a preassembled configuration. In the example,suspensory fixation system280 is assembled to thebar1100, and reference made toFIGS.3A-3E andFIG.12A. Other suspensory fixation systems may assemble using similar philosophies, however. BothFIGS.12B and12C are to be viewed in combination. Stated another way, as provided bothportions1200aand1200bmay be assembled to thereduction bar1100.FIG.12B illustrates assembly ofportion1200bonly with the remainder of the system280 (portion1200a) shown assembled inFIG.12C.Portion1200ais not shown inFIG.12B for clarity of understanding. Similarly,only portion1200ais shown inFIG.12C, withportion1200bremoved from the figure for simplification of explanation only. As packaged thebar1100 is pre-assembled to bothportions1200aand1200b, and bothFIGS.12B and12C should be viewed in combination to view the preassembled configuration.
• Starting withFIG.12B, a front side ofbar1100 is shown, with a portion of the front half ofend1114 removed for improved understanding of the strand routing. Suspensory fixation construct280 may be provided in the pre-assembled configuration, with a tissue anchor, such asbutton100 nested withinslot1150. This is also shown in at leastFIGS.11C,11D and11E.Portion1200bincluding loopedend33amay extend recessed withinend1114, alongchannel1155, acrossspool1113aand into and alongchannel1130 towardsspool1113b. Loopedend33amay then wrap around an outermost circumferential surface ofspool1113bfor a plurality of wraps and then throughcleat1133b, to secure it in place and prevent uncoiling of loopedend33a.Channel1130 may be defined by an interruption in thecircumferential ribs1112 aroundbar1100.Channel1130 may extend parallel to longitudinal axis X-X.Channel1130 may have openings at bothspool1113aandspool1113b, such that looped end33ais assembled substantially recessed withinchannel1155 andchannel1130 in the assembled configuration.Spools1113aand1113bmay extend from and be continuous with ends ofchannel1130.
• FIG.12C illustrates the routing ofportion1200a. Again,FIG.12C is illustrated with a portion of the front half ofend1114 removed for improved understanding of the strand routing. The multiple lengths offlexible strand30 may extend fromanchor100, alongchannel1155 and wraps aroundspool1113a. Lockingpassage38, adjustable loopedend35band loopedend35bmay all wrap around an outermost circumference ofspool1113a(represented in the figure in simplified form to simplify the figure). In addition,flexible loop310 may also wrap aroundspool1113a. Threadingmember305 may extend alongretention channel1140.Retention channel1140 is defined by an interruption in thecircumferential ribs1112, the interruption defining a retention channel width. Retention channel may loosely house threadingmember305, except for a central most end ofretention channel1140, defined by end of circumferential ribs that form a narrowedwidth1141, spaced to pinch a threadingmember tip305a.Retention channel1140 may be continuous withspool1113a. Threadingmember305 may be oriented parallel to longitudinal axis X-X and may be positively retained atend1141. Threading member may be a tube, needle or thick portion of a flexible material.Channel1140 may be continuous with relief orcavity1120. Threadingmember tip305amay extend intorelief1120.Relief1120 may be deeper than channel1140 (best seen inFIG.11E), allowing a user to place a finger or tool withinrelief1120 and grasp threadingelement tip305a. Threadingmember tip305amay be accessible from or extend intorelief1120,relief1120 defining a cavity within thereduction bar1100 that allows a surgeon to access and remove the threadingmember305 from thereduction bar1100.
• A method of tissue repair may therefore start with the obtainingbar1100, pre-assembled with thefixation system280, including bothportions1200aand1200b, as shown inFIGS.12B and12C in combination. A surgeon may first removeportion1200a. This includes first removing the threadingmember305 from thechannel1140 by placing a finger or tool in therelief1120 and engaging atip305aof threadingmember305. Once removed, a portion of the adjustable loop construct280 may then be uncoiled fromspool1113a. This may include uncoiling aflexible loop310, an adjustable free loopedend35b, a loopedend33band at least one lockingpassage38 from thespool1113a. Withportion1200bstill assembled to bar1100, threadingmember305 may be then inserted through a body (tissue/graft or tissue anchor) to couple thesuspensory fixation system280 thereto. While inserting the threadingmember305 through the body, the cortical button (100,200) may remain withinslot1150. While inserting the threadingmember305 through the body, a loopedend33amay remain coiled aroundspool1113b. Inserting the threadingmember305 may include inserting the threadingmember305 through abone hole6awhich first draws loopedend33bthrough thehole6a, and then draws theadjustable loop35bthrough thebone hole6a.
• Once coupled to the body,bar1100 may also serves as a tool to ease coupling the freeadjustable loop end33band free loopedend35btobutton100. After thesuspensory fixation system280 is coupled to the body, the threadingmember310 may be inserted through an aperture (135b) of thebutton100 disposedadjacent surface1124 ofbar1100, to draw loopedend33btherethrough, whilebutton100 is held withinbar slot1150. As shown in at leastFIG.11C,11D,button100 is orientated byslot1150 to exposelateral slots121a,121bandaperture135b.Lateral slots121a,121bmay align withplanar surface1124.End1114 andslot1150 is therefore deep enough to house thebutton100 in this orientation while aligning thelateral slots121a,121bwith theplanar surface1124. Free loopedend35bmay slidingly engage withsurface1124 and be drawn towards the slottedapertures121a,121b, to thread theadjustable loop35bover thetop side108 ofbutton100 and into slottedapertures121a,121b, illustrated inFIG.11E.Surface1124 may be coincident with a portion oflateral slots121a,121b.
• Continuing with the example method, the entire suspensory fixation construct280 may now be removed from thereduction bar1100, including now removingportion1200b, before being reassembled into a reducing configuration. In this reducing configuration,reduction bar1100 may be a tool to impart tension on thesystem280 and reduce theadjustable loop construct32. This tension may also knotlessly lock any locking passages of thesystem280.
• To assemble in the reducing configuration, looped ends33aand33bmay slide, one each, into and alongnotches1123a,1123bto lie around a segment of theircorresponding spools1113a,1113b.Notches1123a,1123bdefine a reduced perimeter relative to theoutermost spools1113a,1113b, having a secondary surface or cut-through that looped ends33a,33bmay lie in, illustrated best inFIG.13A-13B. Looped ends33a,33bmay extend quite a long distance frombutton100, this long distance being cumbersome. The act of reducing thesystem280 may increase this distance further.Bar1100 may preferably be first rotated (indicated asstep1 inFIG.13D) around its longitudinal axis, to shorten the length ofends33a,33bbefore and as the adjustable loop construct reduces. Reducing the adjustable loop construct32 and rotating thebar1100 may be performed sequentially and repeatedly. For example, thebar1100 may first be rotated to wrap a portion of theends33a,33baroundspool1113a,1113b, then tension (indicated by arrow step2) may be applied to reduce the adjustable loop size (which lengthens ends33a,33b). Then thebar1100 may be rotated again to further wrap ends33a,33baround the correspondingspool1113a,1113b), to reduce the distance between thebar1100 andbutton100.
• Illustrated inFIGS.13B and13C, is a cross section ofspool1113a, illustrating the outermostcircumferential surface1313aand asecond surface1323adefined bynotch1123a(only one spool shown, spools may be similar).Spool1113bmay have the same cross section.Second surface1323amay define aplanar surface1313athat traverses thereduction bar1100.Second surface1323amay define a “short cut” that is configured to inhibit the looped ends33a,33bfrom slipping around thespool1113aas the bar is rotated (step1). Each looped ends33a,33bmay be formed with a spice or knot at point “P”.Second surface1323amay define a corner or discontinuity sufficient to limit the looped end from spinning around the spool outcircumference1313a, such that the loopedend33amay preferentially fold over itself (as illustrated inFIG.13C) and wrap, without slipping as thebar1100 is rotated (step1). Eachnotch1123a,1123bis configured to place a looped end (33a,33b) within a segment of its respective spool to inhibit slipping or sliding of the loopedend33a,33bas they are wrap around the correspondingspool1113a,1113b. Notch (1123a,1123b) is configured to form a folded portion of the looped end as thebar1100 is rotated about the longitudinal axis X-X.
• One skilled in the art will realize the disclosure may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing examples are therefore to be considered in all respects illustrative rather than limiting of the disclosure described herein. Scope of the disclosure is thus indicated by the appended claims, rather than by the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Claims (21)

What is claimed is:

1. A cortical button configured to be passed through a bone tunnel in an elongate orientation before being flipped to a deployed configuration, the cortical button comprising:

an oblong body, having a length greater than a width, and a longitudinal axis;

the width extending from a first sidewall to a second sidewall of the body, the first and second sidewalls along the longitudinal axis between a first and a second end, the body also having a lower surface configured to engage an external bone surface when the cortical button is in the deployed configuration; and

a pair of slotted apertures extending through an entire thickness of the body for receiving a loop of a flexible strand therethrough; and

a rib extending from the oblong body lower surface and disposed between the pair of slotted apertures, coextensive along the longitudinal axis with the pair of slotted openings.

2. The cortical button ofclaim 1 further comprising a pair of enclosed apertures, adjacent the pair of slotted apertures, the rib disposed between the pair of enclosed apertures and coextensive along the longitudinal axis with the pair of enclosed apertures.

3. The cortical button ofclaim 2 further comprising a first end aperture disposed between the pair of slotted apertures and the first end, and a second end aperture disposed between the pair of enclosed apertures and the second end.

4. The cortical button ofclaim 3 wherein the first and second end apertures are axially separated from the rib.

5. The cortical button ofclaim 1 wherein the rib is an oblong solid body.

6. The cortical button ofclaim 1 wherein the rib is an oblong body having a longitudinal axis coincident with and parallel to the cortical button longitudinal axis.

7. The cortical button ofclaim 1 wherein the pair of slotted apertures each define medial surfaces that extend through the cortical button thickness and extend directly from lateral side surfaces of the rib.

8. The cortical button ofclaim 1 wherein the pair of slotted apertures each define a lateral opening through one of the first or second sidewalls, and wherein the rib is configured to compensate for a reduced structural integrity of the cortical button, the reduced structural integrity a result of the lateral openings.

9. The cortical button ofclaim 1 wherein the rib extends perpendicularly less than 2 mm from the oblong body lower surface.

10. The cortical button ofclaim 1 wherein the rib extends from the oblong body lower surface a distance that is less than the body thickness.

11. A cortical button comprising:

an oblong body, having a length greater than a width, and a longitudinal axis;

the width extending from a first sidewall to a second sidewall of the body, the first and second sidewalls along the longitudinal axis between a first and a second end, the body also having a lower surface configured to engage an external bone surface when the cortical button is in the deployed configuration; and

a pair of slotted apertures extending through an entire thickness of the body for receiving a loop of a flexible strand therethrough; and

a rib extending from the lower surface and disposed between the pair of slotted apertures and coextensive along the longitudinal axis with the pair of slotted apertures, the body width defining a minimum diameter of a bone tunnel through which the cortical button may be passed, the rib configured to increase the structural integrity of the cortical button while preserving the minimum diameter.

12. The cortical button ofclaim 11 wherein the pair of slotted apertures each define a lateral opening through one of the first or second sidewalls, and wherein the rib is configured to increase the structural integrity and compensate for loss of structural integrity due to the lateral openings.

13. The cortical button ofclaim 11 further comprising a pair of enclosed apertures, adjacent the pair of slotted apertures, the rib disposed between the pair of enclosed apertures and coextensive along the longitudinal axis with the pair of enclosed apertures.

14. The cortical button ofclaim 11 wherein the pair of slotted apertures each define a lateral opening through one of the first or second sidewalls, and wherein the rib is coextensive along the longitudinal axis with the lateral openings.

15. The cortical button ofclaim 11 further comprising a first end aperture and a second end aperture, both axially separated from the rib.

16. The cortical button ofclaim 11 wherein the rib is an oblong solid body.

17. The cortical button ofclaim 11 wherein the rib is an oblong body having a longitudinal axis coincident with and parallel to the cortical button longitudinal axis.

18. The cortical button ofclaim 11 wherein the pair of slotted apertures each define medial surfaces that extend through the cortical button thickness and are continuous with outer lateral side surfaces of the rib.

19. The cortical button ofclaim 11 wherein the rib extends perpendicularly from the lower surface, less than 2 mm.

20. The cortical button ofclaim 11 wherein the rib extends from the lower surface distance that is less than the body thickness.

21-80. (canceled)

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